Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease

Summary

The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.

Timeline

Start

2017-11-29

Primary completion

2019-02-22

Completion

2019-02-22

Publications

• Sun W, Fennimore B, Beaulieu DB, Arsenescu R, Stein AC, Chen J, Lin T, McKnight S, Kadali H, Rosario M, Lirio RA. Vedolizumab Concentrations in Breast Milk: Results from a Prospective, Postmarketing, Milk-Only Lactation Study in Nursing Mothers with Inflammatory Bowel Disease. Clin Pharmacokinet. 2021 Jun;60(6):811-818. doi: 10.1007/s40262-021-00985-4. Epub 2021 Feb 5.

Drugs

Indications